Summary of Listening Session:

The meeting was chaired by Joshua Sharfstein, MD, Principal Deputy Commissioner, FDA and attended by members of FDA’s Transparency Task Force, as well as the industry participants listed above. Industry participants offered the following suggestions for improving FDA transparency to regulated industry. The views presented here do not necessarily represent the views of FDA or the Transparency Task Force.

A. Guidance Development

Provide more information on the status of draft policy documents, especially where FDA has asked industry for input, such as on draft guidances. In many cases, FDA seeks public or industry comment on a draft, then waits months or years before finalizing the document, and provides no information on the status of the document in the interim. Until it is finalized, industry is confused about the status of the policies discussed in the document. Provide information on when a final document is expected and explain reasons for any delay.

Update and finalize guidances in a timely manner. Many languish for years in draft form. Industry needs current, up-to-date guidance to understand FDA’s requirements and expectations for approval. Long periods without guidance stifle new product development because there is insufficient predictability in the approval process. Changes in agency thinking should be communicated as quickly as possible, perhaps through some alternative to finalizing guidances.

When internal conflicts prevent resolution of a pending policy issue, bring the problem to a public scientific forum.

Encourage greater interaction between industry and FDA in the guidance development process. Guidances with heavy input from industry are the most successful: they have the most buy-in and avoid misinterpretations.

B. Requests for Comment

Make transcripts of meetings available in a timely manner when the agency seeks comment on issues raised at the meeting. If the transcript is unavailable until a few days before comments are due, industry is unable to give thoughtful comments.

Schedule meetings and requests for comment at reasonable intervals, and keep dockets open for reasonable periods, so that companies are not overwhelmed by the demands and can provide thoughtful comments.

C. Training and Education

FDA should continue to support training programs in which FDA officials present information to industry about the regulatory process.

D. Rationale for 510(k) Decisions

Post summaries of 510(k) decisions, as is already done by the Office of In Vitro Diagnostics. This would help communicate the regulatory and evidentiary bases for FDA’s decisions.

E. Classification of Recalls

Provide information on how FDA classifies device recalls into one of the three classifications (Class I, II, or III). Many companies are unsure of the criteria and process employed by FDA to assign a classification.

E. Medical Device User Fees

Share information currently presented to stakeholders at quarterly meetings more broadly with the whole industry.